GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world's largest and most forward-thinking companies. Since 2000, we've been at the forefront of the digital revolution - helping create some of the most innovative and widely used digital products and experiences.
Quality Management Analyst Process Analyst
Location
Worldwide
Posted
12 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Quality Management Analyst Process Analyst
GlobalLogic
Role Description Our client is an innovative manufacturer of medical devices in the United States, producing devices and software applications. In this project, you will have a great opportunity to be involved in the full development life cycle of medical software, which is intended to help individuals by processing certain information taken from medical devices to identify health trends and track daily activities. Qualifications - At least 2-5 years of IT industry experience (Software Quality Assurance Engineer/Analyst/process engineer or similar position from Quality Assurance or Process Management sphere) or as a quality/certification/process/metrology specialist in other domains is a must. - Strong knowledge, deep understanding, and practical application of international quality management system standards and regulations (e.g. ISO 9001:2015, ISO 13485). - Experience in auditing/assessment of Quality Management System based on international quality management system standards (e.g. ISO 9001:2015, ISO 13485, FDA Quality System Regulation (21 CFR Part 820)). - Experience in preparation/review of product-specific lifecycle documentation intended to confirm quality of the product. - Good understanding of Risk Management principles and techniques (Failure Mode and Effect Analysis (FMEA), FTA, and others). - Good understanding of medical device SQA principles and related regulations: ISO 13485, IEC 62304, ISO 14971, FDA QSR Part 820, EU MDR. - Good understanding of software V&V methodologies and software development life cycle. - Good understanding of software testing principles. - Ability to work with large amounts of information, produce and organize content in a logical flow. - Strong documentation management skills, ability to review, analyze, and interpret complex documents. - Good analytical skills. - Attention to detail and being a kind of perfectionist. - Ability to cope with routine work. - Team player. - English: Upper Intermediate or higher; ability to communicate with native speakers is a must. Requirements - Leading review and approval of project documentation (such as development plans and reports, verification test plans and reports, etc.), providing feedback and support to the team to ensure timely preparation and readiness of project deliverables. - Review and approval of CSV documentation. - Assessing project activities and deliverables against established procedures, standards, and regulations as per established QMS. - Advising R&D team regarding implementation or adjustment of established processes. - Working closely with engineering, product, and support teams to ensure the quality and accuracy of project deliverables. - Communicating with a customer on quality assurance, process management, and documentation preparation topics. - Collaborating with R&D and product management teams to ensure robust quality processes and regulatory compliance. - This role is critical for ensuring patient safety, product effectiveness, and successful regulatory submissions. Benefits - Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. - Empowering Growth: We foster a culture of continuous learning and professional development, providing timely and comprehensive assistance for every consultant through our dedicated Learning & Development team. - DE&I Matters: We deeply value and embrace diversity, providing equal opportunities for all individuals and fostering an inclusive and empowering work environment. - Career Development: Our corporate culture emphasizes career development, offering abundant opportunities for growth and empowering team members to pursue their career goals with confidence. - Comprehensive Benefits: We provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. - Flexible Opportunities: We prioritize work-life balance by offering flexible opportunities tailored to your lifestyle, including relocation and rotation options for diverse cultural and professional experiences.
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